Manufacturing Operations Cleaning Expert (Temporary contract)
Your mission:
You will be responsible for managing the cleaning processes, ensuring regulatory compliance, leading operational teams, and driving continuous improvements across cleaning in manufacturing operations in a GMP manufacturing environment, particularly within a mammalian asset.
Your responsibilities:
Guide and support the team in implementing and optimizing cleaning processes, ensuring all documentation meets regulatory compliance requirements.
Review and prepare quality records, such as change requests (CRs), deviation reports (DRs), CAPAs.
Act as the Manufacturing Operations representative and subject matter expert (SME) during internal and external audits.
Support and/or execute risk assessments for the cleaning processes related to assigned products and systems to identify areas for improvement and mitigate risks.
Collaborate with the MSAT (Manufacturing Science and Technology) and QA cleaning validation group to improve cleaning process robustness and drive process optimization in routine manufacturing.
Represent Manufacturing in various internal or investment projects, providing input for the setup, commissioning, and qualification of manufacturing cleaning processes.
Your profile:
Previous experience in a GMP environment and knowledge in regulation for cleaning processes, validation, audit readiness.
Knowledge in Compliance, Quality Control, Continuous improvement, Process Optimization.
Ability to work effectively across teams (MSAT, QA, bioprocess engineers) and manage internal projects, from cleaning system setup to qualification.
Soft skills: leadership, problem solving and risk management oriented.
Seniority level: Associate
Employment type: Temporary
Job function: Manufacturing
Industries: Pharmaceutical Manufacturing
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